= Zometa zoledronic acid (a bisphosphonate) Information: FDA warns against excessive dose of Zometa for patients with kidney problems. This may not exceed 4 mg. by injection administered.

March 29, 2005: Medscape

The FDA warns that patients who have kidney problems are not too high a dose of Zometa should get. An excessive dose is dependent on the creatine content including an almost literal translation of the dose description of this warning:

In patients with a baseline value of creatine treatment of 50 ml. to 60 ml. per minute to administer the dose should be reduced to 3.5 mg. (4.4 ml.) Further reductions should be applied in patients with base values of 40 to 49 mL per minute (3.3 mg, 4.1mL) and 30 to 29 mL per minute (3.0 mg, 3.8 mL). The dose should be diluted in 100 ml. sterile 0.9% NaCl or 5% dextrose injection. The FDA recommends that the creatine levels are measured for each dose given Zometa - zoledronic acid. A treatment should decline in renal - kidney problems, the patient should be remembered, defined by an increase in the creatine content of 0.5 mg. / dl. For patients with normal baseline values and an increase of 1.0 MLG / dl. patients with abnormal baseline values. Please consult your doctor or oncologist if you are using Zometa and kidney problems.

That the FDA recommends be Measured serum creatinine prior to administration of Each dose of zoledronic acid. Treatment Should Be with hero in the event of Renal Deterioration, defined as an Increase in creatinine or 0.5 mg / dL for Patient with normal baseline levels and an Increase of 1.0 mg / dL in patient with abnormal baseline levels.

Zometa Dose Reductions Required in Patients With Renal Impairment

March 25, 2005 - The U.S. Food and Drug Administration (FDA) and Novartis Pharmaceuticals have advised healthcare professionals via letter or required dose réductions for zoledronic acid injection (Zometa) When treating advanced cancer in patient with mild to moderate renal impairment, According To an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

Dose Reductions for Patient with a creatinine clearance of 60 mL per minute or less are Calculated to Achieve a target area under the curve (AUC) equal to That of Patients with a clearance of 75 mL per minute (target AUC, 0.66 mg / L · one hour).

Due to the risk of Clinically significant Deterioration in renal function That May progress to renal failure, single doses of zoledronic acid for the treatment of multiple myeloma and meta static bone lesions from solid tumors Should not Exceed 4 mg and the duration of infusion Should Be no Less than 15 minutes, in patients with creatinine clearance Greater Than 60 mL per minute.

In patients with a baseline creatinine clearance of 50 to 60 mL per minute, the dosage Should Be Reduced to 3.5 mg (4.4 mL). Further Reductions are required in patient with baseline clearances ranging from 40 to 49 mL per minute (3.3 mg, 4.1mL) and 30 to 29 mL per minute (3.0 mg, 3.8 mL). Should Be doses diluted in 100 mL of sterile 0.9% NaCl or 5% dextrose injection.

That the FDA recommends be Measured serum creatinine prior to administration of Each dose of zoledronic acid. Treatment Should Be with hero in the event of Renal Deterioration, defined as an Increase in creatinine or 0.5 mg / dL for Patient with normal baseline levels and an Increase of 1.0 mg / dL in patient with abnormal baseline levels.

Treatment Should Be Used resumed at the Same dose prior to treatment upon return of Interruption and creatinine levels to within-10% of the baseline value.

The FDA notes That preexisting renal Insufficiency and multiple cycles of zoledronic acid or Other bisphosphonates are risk factors for subsequent component Deterioration consistently renal therapy. Factors predisposing to renal Deterioration, include Dehydration or administration or Other nephrotoxic drugs, Should Be Identified and managed if Possible.

Healthcare professionals are encouraged to report adverse events related to use of zoledronic acid to Novartis Pharmaceuticals by phone at 1-888-NOW NOVARTIS (1-888-669-6682), online at www.us.zometa.com/contact/hcp/ emailh.jsp or www.us.zometa.com / hcp / tools / medicalinquiry.jsp, or by mail to 1 Health Plaza, East Hanover, NJ 07936.

Alternatively, this information can-be Reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at www.FDA.gov.medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD